India’s largest drugmaker, Sun Pharmaceutical Industries Ltd., announced on Wednesday that its European biotech partner Philogen has voluntarily withdrawn the marketing authorisation application (MAA) for its investigational therapy Nidlegy from the European Medicines Agency (EMA).
Nidlegy, a biological investigational medicinal product, is being developed for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma.
The therapy is being co-developed by Sun Pharma and Philogen for Europe, New Zealand, and Australia.
The MAA for Nidlegy was submitted in June 2024. However, Philogen decided to withdraw the application due to the timing of availability of Chemistry, Manufacturing and Controls (CMC) data and additional clinical information needed to better characterise the benefit-risk profile in patients with locally advanced resectable melanoma. The company said that providing this data within the current regulatory timeline was unlikely.
So far, Nidlegy has been administered to more than 450 patients with various types of skin cancer.
Philogen said it remains in close contact with the EMA and the medical community, with the aim of making Nidlegy available to patients with melanoma and non-melanoma skin cancers as soon as possible. The company intends to resubmit an updated application.
“After careful consideration of the feedback and ongoing dialogue with EMA, we have decided to withdraw the MAA for Nidlegy and resubmit an updated application, in view of the potential of the product in melanoma and beyond. We are working closely together with EMA to address their requests in preparation of the forthcoming resubmission of the MAA,” said Prof. Dr. Dario Neri, CEO and CSO, Philogen.
Shares of Sun Pharmaceutical Industries Ltd. ended 0.15% higher on Tuesday at ₹1,665. The stock has fallen 12% so far in 2025.
